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Periodic Limb Movement

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3041. Enhancing the Response to Rehabilitation After Stroke Using Repetitive Transcranial Magnetic Stimulation (rTMS)

Last Update Posted : April 24, 2013 Sponsor: McGill University Health Center Collaborator: Canadian Institutes of Health Research (CIHR) Information provided by (Responsible Party): Lisa Koski, McGill University Health Center Study Details Study Description Go to Brief Summary: Weakness of the arm and hand results in long-term disability for many persons who suffer a stroke. After the initial recovery phase, only limited gains are achieved by retraining the weak limb to perform daily tasks. However (...) is to test how well this new strategy works to improve recovery in people who have mild to moderate weakness of the arm and hand after stroke. Participants will receive magnetic stimulation of the movement area of the brain just prior to arm and hand training for a series of eight sessions. We will evaluate changes in hand and arm function after the intervention and one month later to see if the changes are maintained. We will also test whether some groups of people benefit more than others from

2009 Clinical Trials

3042. Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years

the day of dose 1 (Day 1) to Day 7 after dose 1 ] Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days of Dose 2 [ Time Frame: From the day of dose 2 (Day 1 (...) ) to Day 7 of dose 2 ] Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Percentage of Participants Reporting Prespecified Systemic Events Within 7 Days of Dose 1 [ Time Frame: From the day of dose 1 (Day 1) to Day 7 of dose 1 ] Systemic

2008 Clinical Trials

3043. The Impact of Salmeterol-Fluticasone on Sleep in Patients With COPD

disordered breathing (apnea-hypopnea index > 15) or presence of central sleep apnea History of narcolepsy, primary hypersomnia, periodic limb movement disorder, or parasomnia History of psychiatric illness Presence of decompensated heart failure Use of prednisone, antibiotic therapy, or new medication for COPD in the previous 3 months Use of any sleep aids History of ≥ 1 COPD exacerbation (defined as requiring oral corticosteroids and/or antibiotics as either an outpatient or inpatient) Known allergy

2008 Clinical Trials

3044. [Trial of device that is not approved or cleared by the U.S. FDA]

: 2 nights ] These measures are the amount of time patients spent in each stage of sleep in minutes. Wake (W), Stages N1,N2,N3 (NREM), and REM (R) Sleep (% TST) [ Time Frame: 2 nights ] Arousal Index [Total, Apnea Hypopnea (AH)-Related, Periodic Limb Movement (PLM)-Related, 'Spontaneous'] [ Time Frame: 2 nights ] The number of arousals and awakenings is registered in the study, and reported as a total number and as a frequency per hour of sleep, which is referred to as an index. The higher (...) or respiratory insufficiency and who are known to have chronically elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 45mmHg). Participants who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days. Participants with untreated, non- Obstructive Sleep Apnea (OSA)/CSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLM Arousal Index > 15). Participants who are unwilling to participate

2008 Clinical Trials

3045. Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery

on a Numerical Rating Scale (NRS) at movement of the operated limb or body region, after titration to comfort according to current postoperative procedures Exclusion Criteria: Participants with active systemic skin disease or active local skin disease that prohibit fentanyl Iontophoretic Transdermal (through the skin) System (ITS) application Participants with a history of allergy or hypersensitivity to fentanyl and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride Participants (...) Convenience (IPAC) Study Start Date : August 2008 Actual Primary Completion Date : September 2008 Actual Study Completion Date : September 2008 Resource links provided by the National Library of Medicine available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Fentanyl ITS 40 microgram (mcg) per 10 minutes of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within a 24 hour period

2008 Clinical Trials

3046. Polysomnography Study of GSK1838262 Extended Release Tablets Versus Placebo in RLS and Associated Sleep Disturbance

Syndrome (RLS) Drug: GSK1838262 Extended Release Tablets Drug: Placebo Phase 3 Detailed Description: Double-blind, multi-center, placebo-controlled, 2-period crossover study which assessed the efficacy and safety of gabapentin enacarbil (GEn; GSK1838262; XP13512) extended release tablets in adults with Restless Legs Syndrome (RLS)-associated sleep disturbance. One hundred thirty-six (136) adult subjects with RLS-associated sleep disturbance and periodic limb movements (PLM) were randomized from 23 (...) Mean Change From Baseline in Periodic Limb Movements Associated With Arousal (PLMAI) at Week 4/10 as Measured by Polysomnography Using LOCF [ Time Frame: Baseline, Week 4/10 (representing the last week of each intervention period, i.e. Weeks 4 and 10) ] PLMAI is defined as the number of Periodic Limb Movements (PLMs or involuntary jerks of the legs that cause a participant to arouse from sleep per hour of sleep). Change from baseline was calculated as the Week 4 and Week 10 values minus

2008 Clinical Trials

3047. Study of ChimeriVaxâ„¢-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

] Solicited injection site: Tenderness, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability. Grade 3 injection site: Tenderness, cries when injected limb is moved or the movement of injected limb is reduced; Erythema and Swelling ≥5 cm. Grade 3 systemic reactions: Fever, temperature >39.5˚C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying Abnormal, >3 hours; Drowsiness, sleeping most (...) representative able to attend all scheduled visits and comply with all trial procedures. Completion of vaccinations according to the national immunization schedule. Exclusion Criteria : Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination. Planned participation in another clinical trial during the present trial period. Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy

2008 Clinical Trials

3048. A Study of Sativex® for Relief of Spasticity in Subjects With Multiple Sclerosis.

, randomised, placebo controlled parallel group study to evaluate the efficacy, safety and tolerability of Sativex® in subjects diagnosed with MS and spasticity. Subjects were screened to determine eligibility and completed a two week baseline period. Subjects then returned to the site for assessment, randomisation and dose introduction. Visits occurred at the end of treatment week two and at the end of the study (treatment week six) or withdrawal. Study Design Go to Layout table for study information (...) . Study Start Date : June 2002 Actual Primary Completion Date : March 2004 Actual Study Completion Date : March 2004 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Sativex Drug: Sativex® containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period

2008 Clinical Trials

3049. Behavioral Insomnia Therapy For Those With Insomnia and Depression

on the basis of a SCID interview meet DSM-IV criteria for Antisocial Personality Disorder or Borderline Personality Disorder on the basis of a SCID II interview schedule report frequent travel across time zones or work rotating or night shifts meet criteria for sleep apnea, restless legs syndrome or Circadian Rhythm Sleep Disorder on the basis of the Duke Structured Interview of Sleep Disorders (DSISD) have an apnea-hypopnea index > 15 or periodic limb movement-related arousal index > 15 per hour of sleep (...) new information about the short and long-term management of those highly challenging and difficult to treat patients with insomnia comorbid to MDD. Hypothesis I asserts that the combined CBT-I+AD therapy will produce significantly greater pre-to-post therapy improvements in sleep continuity measures than will the 2 mono-therapy conditions. The primary outcomes for these hypotheses are subjective (sleep diary) measures of TWT and SE. These sleep measures are recorded daily for 2-week periods

2008 Clinical Trials

3050. Efficacy of Continuous Positive Airway Pressure in Reducing Oxidative Stress in Individuals With Sleep Apnea

completion Supplemental oxygen use Primary sleep disorder other than sleep apnea (e.g., periodic limb movement disorder) Severe chronic insomnia or circadian rhythm disorder with less than 4 hours of sleep per night, chronic problems falling asleep within 1 hour of bedtime, or chronic problems with early morning awakenings Unstable medical conditions (e.g., new onset or changing angina; heart attack or congestive heart failure exacerbation documented within the 6 months before study entry; high grade (...) pressure CPAP for 8 weeks. Visit 3 will occur 1 week after beginning CPAP treatment and will include a fasting blood test. During treatment, participants will be periodically contacted by a technician to check on equipment status. Upon completing treatment, participants will undergo repeat tests from Visit 2, except that they will wear the CPAP mask in the overnight sleep test. This fourth study visit will mark the completion of treatment for participants assigned to the lower pressure CPAP

2008 Clinical Trials

3051. Sub-Acute Stroke Rehabilitation With AMES

University of California, San Francisco Shirley Ryan AbilityLab Eisenhower Medical Center Information provided by (Responsible Party): AMES Technology Study Details Study Description Go to Brief Summary: The AMES device is designed to produce functional cortical changes by:(1) assisting the subject as he/she attempts to move the limb (assisted movement) and (2) enhancing movement sensation by vibrating the muscles during movement (enhanced sensation). The primary hypothesis is that the combination (...) the leading cause of long-term disability in the U.S.. Existing rehabilitation therapies have not been effective in returning all stroke survivors to full motor recovery. The AMES device was designed to be able to provide therapy for the ankle joint and the hand (fingers/wrist). Subjects may qualify for one or two limbs. In this 18 treatment sessions, double-blinded, control study, AMES therapy will be provided in addition to the usual physician-ordered rehabilitation during the sub-acute period following

2007 Clinical Trials

3052. Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced Dyskinesia

disease is a progressive neurological disorder characterized by tremor, bradykinesia, rigidity, gait and postural instability and a variety of nonmotor symptoms. While levodopa effectively alleviates all symptoms of Parkinson's disease and restores motor function, within 3 to 5 years the majority of Parkinsonian patients develop levodopa-induced side effects, mainly dyskinesias (involuntary and uncontrolled movements such as twisting of a hand or a limb) and wearing off (progressive shortening (...) research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 30 Years to 80 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Male and female patients aged 30-80 years old (both ages included). Use of adequate and effective birth control measures (not including the rhythm method) during the study period and up to 3 months after the end of study in men

2008 Clinical Trials

3053. The Role of Dopamine Metabolism in the Antidepressant Effects of Sleep Deprivation and Sertraline in Depressed Patients

of the study Irregular sleep-wake schedules (nightshift, jet lag) Use of CNS medications which may affect sleep or functional brain imaging (i.e., use of sleeping pills, antidepressants or other mood stabilizers or other medications which may affect the sleep EEG) Sleep apnea, periodic limb movements of sleep, narcolepsy, circadian sleep phase disorders Donation or loss of blood (>400 ml) within the past month Current or very recent intercurrent illnesses, painful conditions or other disorders, which

2007 Clinical Trials

3054. Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

(Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 defined as: Pain, cries when injected limb is moved or movement of limb reduced; Erythema and Swelling, ≥ 5 cm; Extensive Swelling of Vaccinated Limb, All; Pyrexia, ≥ 39ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feeds or most feeds; Irritability, inconsolable. Eligibility Criteria Go to Information (...) immunosorbent assay (ELISA) for Tetanus (T); neutralization assay for Poliovirus types 1, 2, and 3; and ELISA for Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA). Number of Participants With Solicited Injection Site and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRP~T [ Time Frame: Day 0 up to Day 7 post-booster vaccination ] Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia

2008 Clinical Trials

3055. Subacromial Corticosteroid Injection for Hemiplegic Shoulder Pain

to hemorrhagic or nonhemorrhagic stroke ≤ 4/5 on manual muscle testing for the deltoid on the affected side if isolated movement is present post-stroke duration ≥ 1-mo, but < 24-mo shoulder pain sustained for ≥ 1-mo BPI 12 ≥ 4 (pain scale) willing and able to report pain and other conditions throughout the 4-mo study period positive Neer's test Exclusion Criteria: evidence of joint or overlying skin infection > 2 opioid and/or nonopioid analgesic for shoulder pain (i.e., > 2 regardless of class) regular (...) table represent the comparison of week 12 to baseline using least squares means from the linear mixed model, but data from all time points are included in the Statistical Analyses to arrive at the reported slopes/group x time interactions. Secondary Outcome Measures : Fugl-Meyer Motor Assessment, Upper Limb Domain [ Time Frame: Baseline, weeks 4, 8, 12 (4 times) ] Evaluates and measures recovery in post-stroke hemiplegic patients. Items are scored on a 3-point ordinal scale: 0 = cannot perform

2008 Clinical Trials

3056. Clinic-Based AMES Treatment of Stroke

): Paul J. Cordo, Oregon Health and Science University Study Details Study Description Go to Brief Summary: This study investigates whether assisted movement with biofeedback and muscle vibration applied to the lower limb reduces impairment and improves gait. Condition or disease Intervention/treatment Phase Stroke Cerebrovascular Accident Device: Assisted movement and enhanced sensation Phase 1 Phase 2 Detailed Description: The hypothesis of this study is that chronic stroke survivors, more than one (...) Enrollment : 3 participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Clinic-Based Ames Treatment of the Lower Extremity in Chronic Stroke Subjects Study Start Date : April 2008 Actual Primary Completion Date : November 2009 Actual Study Completion Date : November 2009 Arms and Interventions Go to Arm Intervention/treatment Experimental: Test treatment group Device: Assisted movement and enhanced sensation Device: Assisted movement

2007 Clinical Trials

3057. Botox Clinical Trial

Description Go to Brief Summary: The surgery to correct leg & foot deformities in children is a lengthy, & sometimes, difficult procedure. Metal frames are attached to the leg and / or foot and over a period of time the frame is manipulated to obtain the corrected position. During this period the muscles & skin become very tight which causes pain & may pull the joint out of position. When this happens it is sometimes necessary to stop the treatment before the best position is obtained. This means (...) Intervention/treatment Phase Leg Length Inequality Foot Deformities Drug: Botox Other: Saline Phase 4 Detailed Description: Excessive soft tissue tension (i.e.. tight muscles and associated tissues) is the most limiting factor in lengthening and correction of limb length deficiency. Bone lengthening is achieved by surgically breaking the bone and with the use of an extending device, commonly placed on the outside of the limb, the bones ends are distracted. One millimetre a day is commonly the amount

2008 Clinical Trials

3058. Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease

: Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease Study Start Date : October 2008 Actual Primary Completion Date : May 2011 Actual Study Completion Date : August 2011 Resource links provided by the National Library of Medicine related topics: related topics: Arms and Interventions Go to Arm Intervention/treatment Experimental: Tai Chi Behavioral: Tai Chi a set of pre-designed Tai Chi Movements Active Comparator: B. Strength training Behavioral: Strength (...) , with a disease severity rating of stage I to IV on the Hoehn and Yahr scale (Hoehn & Yahr, 1967) At least 1 score of 2 or more for at least 1 limb for either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS) Stable medication usage Not participated in a structured exercise program (i.e., not involved in any routine, organized physical activity program lasting 30 minutes or more per day, such as a gym program or regularly scheduled instructor-led exercise class

2008 Clinical Trials

3059. Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia

than 2 months Their insomnia is considered to derive from sleep apnoea or periodic limb movements during sleep, judged by their clinicians. Patients who engage in work involving night-shift, which might influence sleep status Patients currently taking methylphenidate or modafinil. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor (...) and 23 on the 17-GRID-HAMD. Agreement to the requirements that i) no change of medication will be allowed during the first 4 weeks of their study period, and ii) all the treatment sessions both of bBT-I and of TAU will be audiotaped for the purpose of checking their adherence to the protocol Exclusion Criteria: Their mental or physical status at the time of entry into the trial is regarded as so critical as to need immediate hospitalisation A serious suicidal risk, defined as a score of 3 or more

2008 Clinical Trials

3060. The Effect of Exercise on Individuals With Parkinson's Disease

of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity Number of Agonist Bursts [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ] This is the number of agonist bursts prior to peak velocity. Co-contraction During Limb Acceleration [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ] the amount of agonist (...) and antagonist activity present during limb acceleration. Qant [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ] The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement Time to Peak Velocity [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ] Time of the onset of the movement to peak velocity. Peak Movement Velocity [ Time Frame: obtained during

2007 Clinical Trials

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